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EN ISO 8536-16:2025

Infusion equipment for medical use - Part 16: Infusion sets for single use with volumetric infusion controllers (ISO 8536-16:2025)

Publication date:   Oct 15, 2025

General information

60.60   Standard published   Aug 13, 2025

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Scope

This document specifies the requirements for sterilized, single-use, gravity feed infusion sets, used together with the volumetric infusion controllers of IEC 60601-2-24.

Life cycle

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PUBLISHED
EN ISO 8536-16:2025
60.60 Standard published
Aug 13, 2025